MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Perforation (2001)

Event Date 02/22/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2022.During the procedure, "the wall of the common bile duct had been torn down to the muscularis layer" when the spyglass catheter was inserted.A fully covered biliary stent (manufacturer unknown) was placed to manage the perforation.There was no reported issue with the spyscope ds ii, and the procedure was completed with the spyscope ds ii.The patient reported "slight pain" post procedure, however, the patient's current condition is reported to be fine.

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: SPYSCOPE DS II ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13802924
• MDR Text Key: 288116501
• Report Number: 3005099803-2022-01439
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0027676367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 69 KG